A Gilead Sciences HIV drug designed for twice-yearly dosing is now approved for use in Europe, providing a new treatment option for patients whose virus no longer responds to currently available therapies.
The European Commission approval announced Monday covers use of the drug, lenacapavir, in combination with other antiretrovirals in adults with HIV. The drug, which patients start with an oral dose before proceeding to the long-acting injection, will be marketed under the brand name Sunlenca.
Though HIV/AIDS has no cure, antiretroviral therapy can keep the virus in check and give the immune system a chance to recover. Antiviral drugs work by addressing part of a virus’s life cycle, preventing viral replication. Whereas most antivirals target one stage of the life cycle, Foster City, California-based Gilead designed Sunlenca to block HIV at multiple stages. Furthermore, the company said that its new HIV drug has no known cross resistance with other classes of drugs currently available for treating HIV. That means it can be used in combination with other HIV drugs.
The European Commission based its decision on the results of a placebo-controlled Phase 2/3 study enrolling 72 patients whose HIV had become resistant to multiple therapies. The results showed that 83% of study participants who received the experimental Gilead drug in addition to other therapies achieved an undetectable viral load at week 52, meeting the main goal of the study. Gilead also reported that patients treated with the drug showed an increase in levels of CD4 cells, a type of immune cell whose count is used to gauge the health of the immune system in patients with HIV. The most common adverse reactions reported were nausea and injection site reactions. Results from the study were published in May in the New England Journal of Medicine.
For years, the standard antiviral treatment for HIV consisted of daily pills. Last year, FDA approval of ViiV Healthcare’s Cabenuva gave patients the option of a once-monthly treatment given as an injection. That decision covers patients with no history of failing on other treatments and no known or suspected resistance to the two main antiviral components of the drug. Gilead’s new HIV drug provides an option for those whose virus has developed drug resistance.
“Lenacapavir is a unique and potent medicine with the potential for flexible dosing options,” Gilead Chairman and CEO Daniel O’Day said in a prepared statement. “Following today’s approval, it will now be the only twice-yearly treatment for people who struggle with multi-drug resistant HIV.”
The European regulatory nod is Sunlenca’s first one. The drug had run into hurdles at the FDA; in March, the U.S. agency turned down Gilead’s application for the drug due to a manufacturing issue. The regulator had questions about the compatibility of the drug with the glass used in the vials. Gilead resubmitted its application in June. A regulatory decision is now expected by Dec. 27. Gilead said that additional regulatory submissions and decisions are expected later this year.